Cobalt™/Crome™ MRI SureScan™ ICD and CRT-D Systems

Indications

The Cobalt and Crome HF CRT-D MRI SureScan systems are indicated for use in patients who are at significant risk of developing atrial and/or life-threatening ventricular arrhythmias and who have heart failure with ventricular arrhythmias. Heart failure patients must have experienced one or more of the following conditions:

• NYHA Functional Class III or IV patients who remain symptomatic despite stable, optimal medical therapy and have LVEF ≤ 35% and a prolonged QRS duration
• NYHA Functional Class II patients who have left bundle branch block (LBBB) with a QRS duration ≥ 130 ms and a left ventricular ejection fraction ≤ 30%
• NYHA Functional Class I, II, or III who are on stable, optimal medical therapy (if indicated) and have LVEF ≤ 50%, atrioventricular block (AV block), and are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. 

The Cobalt and Crome VR and DR ICD MRI SureScan systems are indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, atrial and/or life-threatening ventricular arrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies.

MRI Conditions for Use

Medtronic SureScan ICD and CRT-D systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. ICD and CRT-D SureScan system patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing. A complete SureScan defibrillation system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com/. Any other combination may result in a hazard to the patient during an MRI scan.

Contraindications

The Cobalt and Crome VR and DR ICD, and CRT-D MRI SureScan systems are contraindicated for use in the following situations:

• If implanted with a unipolar pacemaker
• If incessant VT or VF exists
• If the primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF
• If tachyarrhythmias with transient or reversible causes exist, including the following known issues: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, and sepsis

Warnings and Precautions

Changes in a patient’s disease and/or medications may alter the efficacy of thedevice’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. 

Patients and their implanted systems must be screened to meet the following requirements for MRI: no lead extenders, lead adaptors, or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; the device must be operating within the projected service life; and the system must be implanted in the left or right pectoral region.

Potential Adverse Events

Potential adverse events include, but are not limited to, the following events: allergic reactions, atrial fibrillation, bradyarrhythmia, cardiac arrest, device migration, discomfort, dizziness, dyspnea, erosion, excessive fibrotic tissue growth, heart failure or loss of CRT (for CRT-D patients), hematoma, hemorrhage, inability to deliver therapy, inappropriate shock, infection, lead migration/dislodgement, lethargy, loss of pacing, mental anguish, necrosis, nerve damage, oversensing, palpitations, seroma, syncope, tachyarrhythmia, tissue damage due to heating of the device, undersensing, and wound dehiscence. 

Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, spontaneous tachyarrhythmia, potential for VT/VF induction, device heating that results in tissue damage, stimulation of the leads that results in continuous capture, VT/VF, hemodynamic collapse, damage to the device or the leads, causing the system to fail or treat the patient’s condition incorrectly, and movement or vibration of the device or the leads, resulting in dislodgement.

See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and adverse events. See the MRI SureScan Technical Manual before performing an MRI Scan. For further information, call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com or mrisurescan.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

Percepta™/Percepta™ Quad, Serena™/Serena™ Quad, and Solara™/Solara™ Quad CRT-P MRI SureScan™ System (Percepta/Serena/Solara CRT-P MRI SureScan Systems) Implantable Cardiac Pacemakers with Cardiac Resynchronization Therapy 

Indications

The Percepta/Serena/Solara CRT-P MRI SureScan Systems are indicated for NYHA Functional Class III and IV patients who remain symptomatic despite stable, optimal heart failure medical therapy and have a LVEF ≤ 35% and a prolonged QRS duration and for NYHA Functional Class I, II, or III patients who have a LVEF ≤ 50%, are on stable, optimal heart failure medical therapy if indicated and have atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing.  Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post implant.  Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in activity.  Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.  Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrythmias in patients with one or more of the above pacing indications.

A complete SureScan pacing system is required for use in the MR environment. A complete SureScan pacing system includes a SureScan device with Medtronic SureScan leads or a Model 6725 pin plug for the right atrial port. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com.

Contraindications

The Percepta/Serena/Solara CRT-P MRI SureScan Systems are contraindicated for concomitant implant with another bradycardia device and concomitant implant with an implantable cardioverter defibrillator.  There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient’s age and medical condition, however, may dictate the particular pacing system, mode of operation, and implant procedure used by the physician.  Rate-responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate.  Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter.  Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms.  Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance.  Anti-tachycardia pacing (ATP) therapy is contraindicated in patients with an accessory antegrade pathway.

Warnings and Precautions 

A complete SureScan pacing system is required for use in the MR environment. Before performing an MRI scan, refer to the MRI technical manual for MRI-specific warnings and precautions. A complete SureScan pacing system includes a SureScan device with Medtronic SureScan leads or a Model 6725 pin plug for the right atrial port. Any other combination may result in a hazard to the patient during an MRI scan. Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset or device damage. Do not place transthoracic defibrillation paddles directly over the device. Certain programming and device operations may not provide cardiac resynchronization.  Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm.  In this mode, patients may experience loss of cardiac resynchronization therapy and / or loss of AV synchrony.  For this reason, the device should be replaced prior to ERI being set. Use of the device should not change the application of established anticoagulation protocols. Patients and their implanted systems must be screened to meet the following requirements for MRI: no implanted lead extenders, lead adaptors, or abandoned leads; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; a SureScan pacing system implanted in the left or right pectoral region. Additionally, for patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is programmed to On, no diaphragmatic stimulation is present at a pacing output of 5.0 V and at a pulse width of 1.0 ms.

Claria MRI™/Claria MRI™ Quad CRT-D SureScan™ Implantable Cardioverter Defibrillator with Cardiac Resynchronization System (CRT-D MRI System)

Indications for Use

Lead Integrity Alert

Contraindications 

Warnings and Precautions 

Potential Complications 

Amplia MRI™/Amplia MRI™ Quad CRT-D SureScan™ Implantable Cardioverter Defibrillator with Cardiac Resynchronization System (CRT-D MRI System)

Indications for Use

• The Amplia MRI CRT-D device
• A SureScan right atrial pacing lead or a Model 6725 pin plug for the right atrial port
• A SureScan left ventricular pacing lead
• A SureScan defibrillation lead

Lead Integrity Alert

The RV Lead Integrity Alert feature is intended primarily for patients who have a Medtronic ICD or CRT-D device and a Sprint Fidelis lead (Models 6949, 6948, 6931, and 6930), based on performance data. The RV LIA feature may not perform as well with a St. Jude Riata/Durata lead or a Boston Scientific Endotak lead as it does when used with a Medtronic Sprint Fidelis lead. This is because different lead designs may have different failure signatures and conditions that may or may not be detected early by the RV LIA feature.

Contraindications 

Warnings and Precautions

Potential Complications 

Attain Stability™ Quad MRI SureScan™ Lead 

Indications

The Attain Stability Quad MRI SureScan 4798 steroid eluting, quadripolar electrode, IS4 transvenous lead is indicated for chronic pacing in the left ventricle via the cardiac vein, when used with a compatible Medtronic Cardiac Resynchronization Therapy (CRT) system. Extended bipolar pacing is available using this lead in combination with a compatible cardioverter defibrillator CRT system and RV defibrillation lead.
 

Contraindications

The Attain Stability Quad lead is contraindicated for the following:

Coronary vasculature – These leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.

Steroid use – This lead is contraindicated in patients for whom a single dose of 288 µg of dexamethasone acetate may be contraindicated.
 

Warnings and Precautions

Diathermy is a treatment that involves the therapeutic heating of body tissues. Diathermy treatments include high frequency, short wave, microwave, and therapeutic ultrasound. Except for therapeutic ultrasound, do not use diathermy treatments on cardiac device patients. Diathermy treatments may result in serious injury or damage to an implanted device and lead system. Therapeutic ultrasound (including physiotherapy, high intensity therapeutic ultrasound, and high intensity focused ultrasound), is the use of ultrasound at higher energies than diagnostic ultrasound to bring heat or agitation into the body. Therapeutic ultrasound is acceptable if treatment is performed with a minimum separation distance of 15 cm (6 in) between the applicator and the implanted device and lead system, as long as the ultrasonic beam is pointing away from the device and lead system.

A complete SureScan system is required for use in the MRI environment. Before performing an MRI scan, refer to the MRI Technical Manual for important information about procedures and MRI-specific warnings and precautions. Patients and their implanted systems must be screened to meet the following requirements for MRI: no implanted lead extenders, lead adaptors, or abandoned leads; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; the SureScan system is implanted in the left or right pectoral region; the SureScan device is operating within the projected service life; no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is programmed to On. For pacemaker-dependent patients, it is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms. A higher pacing capture threshold may indicate an issue with the implanted lead.

Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging, maximum spatial gradient ≤ 20 T/m, and maximum gradient slew rate performance per axis ≤ 200 T/m/s. 1.5T scanners must be operated in Normal Operating Mode (whole body averaged specific absorption rate (SAR) ≤ 2.0 W/kg, head SAR ≤ 3.2 W/kg). 3T scanners must be operated in First Level Controlled Operating Mode or Normal Operating Mode. B1+RMS must be ≤ 2.8 μT when the isocenter (center of the bore) is inferior to the C7 vertebra. Scans can be performed without B1+RMS restriction when the isocenter is at or superior to the C7 vertebra.
 

Potential Adverse Events

Potential adverse events related to the use of transvenous leads include, but are not limited to, the following patient-related conditions: air embolism; avulsion or other damage to the endocardium, valve, or vein (particularly in fragile hearts); cardiac dissection; cardiac perforation; cardiac tamponade; coronary sinus dissection; death; endocarditis; erosion through the skin; extracardiac muscle or nerve stimulation; fibrillation or other arrhythmias; heart block; heart wall or vein wall rupture; hematoma/seroma; infection; lead conductor fracture or insulation failure; lead dislodgement; myocardial irritability; myopotential sensing; pericardial effusion; pericardial rub; pericarditis; pneumothorax; rejection phenomena (local tissue reaction, fibrotic tissue formation); threshold elevation or exit block; thrombosis; thrombotic embolism.

Potential MRI complications for the SureScan system include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse; spontaneous tachyarrhythmia occurring during the scan that is not detected and treated because tachyarrhythmia detection is suspended while MRI SureScan is programmed to On; potential for VT/VF induction when the patient is programmed to an asynchronous pacing mode during MRI SureScan; device heating resulting in tissue damage in the implant pocket or patient discomfort or both; or damage to the functionality or mechanical integrity of the device resulting in the inability of the device to communicate with the programmer.

See the MRI Technical Manual before performing an MRI scan and Device Manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.  For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com or www.mrisurescan.com.

Caution:  Federal law (USA) restricts this device to sale by or on the order of a physician.
 

Brief Statement: Attain Ability™ and Attain Performa™ MRI SureScan™ Leads 

Indications

Contraindications

Warnings and Precautions

Potential Complications 

Caution:  Federal law (USA) restricts this device to sale by or on the order of a physician.

Medtronic Attain Ability Model 4196, Ability Plus Model 4296, and Ability Straight Model 4396 Leads

Steroid eluting, dual electrode, transvenous, over the wire, cardiac vein pacing leads. The Model 4396 lead has tined fixation.

Indications

The Attain Ability Models 4196, 4296, and 4396 steroid eluting, dual electrode, IS-1 transvenous leads are indicated for chronic pacing and sensing in the left ventricle via the cardiac vein, when used in conjunction with a compatible Medtronic Cardiac Resynchronization Therapy (CRT) system. Extended bipolar pacing is available using this lead in combination with a compatible CRT-D system and RV defibrillation lead or with a compatible CRT-P system and RV pacing lead. Additionally, unipolar pacing is available using the leads in combination with a compatible CRT-P system.
 

Contraindications

Coronary vasculature - The leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.

Steroid use - Do not use in patients for whom a single dose of 232 µg of dexamethasone acetate cannot be tolerated.
 

Warnings and Precautions

The Model 4196, 4296, and 4396 were designed for optimal pacing when used in a unipolar or extended bipolar configuration. The standard bipolar configuration may result in markedly elevated pacing thresholds or produce anodal stimulation.

Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development. The clinical studies for these leads were not designed to evaluate the removal of left ventricular leads from the coronary venous vasculature.

Output pulses, especially from unipolar devices, may adversely affect device sensing capabilities. If a patient requires a separate stimulation device, either permanent or temporary, allow enough space between the leads of the separate systems to avoid interference in the sensing capabilities of the devices. Previously implanted pulse generators and implantable cardioverter defibrillators should generally be explanted.

People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs) and accompanying leads should not receive diathermy treatment.  The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, and/or the need to reprogram or replace the device.

Leads should be handled with great care at all times. Use an anchoring sleeve with all leads. Ensure the anchoring sleeve is positioned close to the lead connector pin, to prevent inadvertent passage of the sleeve into the vein. Use care when handling stylets. Any severe bending kinking, stretching, handling with surgical instruments, or excessive force when inserting a stylet may cause permanent damage to the lead. When using Model 4196, 4296, or 4396 leads, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length). Other sytlets may extend beyond the lead tip causing lead tip seal damage or injury or perforation of the cardiac vein or heart. Rust stylets are not recommended with these leads due to the risk of conductor coil or insulation perforation.

Use care when handling guide wires. Damage to the guide wire may prevent the guide wire from performing accurate torque response control and may cause vessel damage. Do not use excessive force to retract the guide wire from the lead. Refer to the literature packaged with the guide wire for additional information on guide wires.

Do not use magnetic resonance imaging (MRI) on patients who have this device implanted. MRI can induce currents on implanted leads, potentially causing tissue damage and the induction of tachyarrhythmias.

For the Model 4196, 4296, or 4396 leads, total patient exposure to dexamethasone acetate should be considered. Drug interactions of dexamethasone acetate with this lead have not been studied. It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone acetate apply to the use of this highly localized, controlled-release lead. For a list of potential adverse effects, refer to the Physicians' Desk Reference.

Do not force the guide catheter or leads if significant resistance is encountered. Use of guide catheters and/or leads may cause trauma to the heart.

Keep external defibrillation equipment nearby for immediate use during acute lead system testing, the implant procedure, or whenever arrhythmias are possible or intentionally induced during the post-implant testing. Backup pacing should be readily available during implant. Use of the delivery system or leads may cause heart block.

To minimize the likelihood of trauma to the vein and to maintain lead flexibility while advancing the lead through the vein, keep the stylet withdrawn 1 to 2 cm or select a more flexible stylet.

Do not insert the proximal end of the guide wire through the lead tip seal without using the guide wire insertion tool. Inserting the guide wire without the guide wire insertion tool could cause damage to the lead tip seal or to the conductor core or insulation.

During lead implant and testing, use only battery-powered equipment or line-powered equipment specifically designed for this purpose to protect against fibrillation that may be caused by alternating currents.
 

Potential Complications

Potential complications related to the use of tranvenous leads include, but are not limited to the following patient-related conditions: cardiac dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis, erosion through the skin, extracardiac muscle or nerve stimulation, fibrillation or other arrhythmias, heart block, heart wall or vein wall rupture, hematoma/seroma, infection, myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, rejection phenomena, threshold elevation, thrombosis, thrombotic or air embolism, and valve damage.

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
 

Brief Statement: Medtronic Attain Bipolar OTW Model 4194 Lead

Indications

The Attain Bipolar OTW Model 4194 steroid eluting, IS-1 transvenous lead is indicated for chronic pacing and sensing in the left ventricle via the cardiac vein, when used in conjunction with a compatible Medtronic Cardiac Resynchronization Therapy (CRT) system. Extended bipolar pacing is available using this lead in combination with a compatible CRT-D system and RV defibrillation lead or with a compatible CRT-P system and RV pacing lead.
 

Contraindications

Coronary vasculature - The leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram. 

Steroid use - Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphatecannot be tolerated.
 

Warnings/Precautions

The Model 4194 was designed for optimal pacing when used in a bipolar configuration. The standard bipolar configuration may result in markedly elevated pacing thresholds or produce anodal stimulation.

Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development. The clinical studies were not designed to evaluate the removal of left ventricular leads from the coronary venous vasculature.

Output pulses, especially from unipolar leads, may adversely affect device sensing capabilities. Previously implanted pulse generators, implantable cardioverter defibrillators, and leads should generally be explanted.

People with metal implants such as pacemakers, Implantable Cardioverter Defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, and/or the need to reprogram or replace the device.

Leads should be handled with great care at all times. Use an anchoring sleeve with all leads. Ensure the anchoring sleeve is positioned close to the lead connector pin, to prevent inadvertent passage of the sleeve into the vein. Use care when handling stylets. Any severe bending, kinking, stretching, handling with surgical instruments, or excessive force when inserting a stylet, may cause permanent damage to the lead. When using Model 4194 leads, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length). Other stylets may extend beyond the lead tip causing lead tip seal damage or injury, or perforation of the cardiac vein or heart. Rust stylets are not recommended with this lead due to the risk of conductor coil or insulation perforation.

Use care when handling guide wires. Damage to the guide wire may prevent the guide wire from performing accurate torque response control and may cause vessel damage. Do not use excessive force to retract the guide wire from the lead. Refer to the literature packaged with the guide wire for additional information on guide wires.

Do not use Magnetic Resonance Imaging (MRI) on patients who have this device implanted. MRI can induce currents on implanted leads, potentially causing tissue damage and the induction of tachyarrhythmias.

For the Model 4194 lead, total patient exposure to dexamethasone sodium phosphate should be considered. Drug interactions of dexamethasone sodium phosphate with this lead have not been studied. It has not been determined if whether the warnings, precautions, or complications usually associated with injectable dexamethasone sodium phosphate apply to the use of this highly localized, controlled-release lead. For a list of potential adverse effects, refer to the Physicians' Desk Reference.

Do not force the guide catheter and/or leads if significant resistance is encountered. Use of the guide catheters and/or leads may cause trauma to the heart.

Keep external defibrillation equipment nearby for immediate use during the acute lead system testing, the implant procedure, or whenever arrhythmias are possible or intentionally induced during the post-implant testing. Backup pacing should be readily available during implant. Use of the delivery system or leads may cause heart block.

To minimize the likelihood of trauma to the vein and to maintain lead flexibility while advancing the lead through the vein keep the stylet withdrawn 1-2 cm or select a more flexible stylet.

Do not insert the proximal end of the guide wire through the lead tip seal without using the guide wire insertion tool. Inserting the guide wire without the guide wire insertion tool could cause damage to the lead tip seal or to the conductor core or insulation.

During lead implant and testing, use only battery powered equipment or line-powered equipment specifically designed for this purpose to protect against fibrillation that may be caused by alternating currents.
 

Potential Complications

Potential complications related to the use of transvenous leads include, but are not limited to the following patient-related conditions: cardiac dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis, erosion through the skin, extracardiac muscle or nerve stimulation, fibrillation or other arrhythmias, heart block, heart wall or vein wall rupture, hematoma/seroma, infection, myocardial irritability, myopotential sensing, pericardial effusion, epicardial rub, pneumothorax, rejection phenomena, threshold elevation, thrombosis, thrombotic or air embolism, and valve damage.

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.  For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution:  Federal law (USA) restricts these devices to sale by or on the order of a physician.
 

Brief Statement: Medtronic Attain StarFix Model 4195 Lead

Indications

The Attain StarFix Model 4195 steroid eluting, transvenous lead with deployable lobes is intended for chronic pacing and sensing of the left ventricle via a cardiac vein, when used in conjunction with a compatible implantable pulse generator or implantable cardiac defibrillator.
 

Contraindications

Coronary vasculature - This lead is contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram. 

Steroid use - Do not use in patients for whom a single dose of 30 μg (micrograms) of beclomethasone dipropionate (BDP) cannot be tolerated.
 

Warnings/Precautions

Leads, stylets, and guide wires should be handled with great care at all times. When using the Model 4195 lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length). Verify that the stylet does not extend beyond the lead tip prior to inserting the lead in the delivery system. Implanting the lead with the stylet extending beyond the lead tip could cause injury or perforation of the cardiac vein or heart.

Output pulses, especially from unipolar leads, may adversely affect device sensing capabilities.

Backup pacing should be readily available during implant. Use of leads may cause heart block.

For the Attain StarFix Model 4195 lead, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting multiple leads. No drug interactions with inhaled beclomethasone 17,21-dipropionate have been described. Drug interactions of beclomethasone 17,21-dipropionate with the Model 4195 lead have not been studied.

People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, or the need to reprogram or replace the device.

Do not use magnetic resonance imaging (MRI) on patients who have this device. MRI can induce currents on implanted leads, potentially causing tissue damage and the induction of tachyarrhythmias.

Always use an acute retention clip to reposition or remove the lead. Always attempt to undeploy the lobes before repositioning or removing the lead. If a lead must be removed or repositioned, consider referring the case to an experienced extraction center. Do not implant the acute retention clip.

Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.
 

Extraction Warning

The risk and difficulty of removing the Medtronic Attain StarFix Model 4195 lead after a long implant time has not been studied. In light of the novel fixation mechanism of the Model 4195 lead, there may be unique risk and difficulty associated with chronic removal. If a lead must be removed or repositioned, consider referring the case to an experienced extraction center. Do not implant the acute retention clip.
 

Potential Complications

Potential clinical complications resulting from the use of transvenous leads include, but are not limited to the following: air embolism, avulsion of the endocardium, valve, or vein, cardiac dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis and pericarditis, erosion through the skin, extracardiac muscle or nerve stimulation, fibrillation or other arrhythmias, heart block, heart wall or vein wall rupture, hematoma/seroma, infection, myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, rejection phenomena, threshold elevation, thrombosis, thrombotic embolism, and valve damage.

See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution:  Federal law (USA) restricts this device to sale by or on the order of a physician.